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Clinical Database Registries
Cabrini Research Annual Report 2020-21 Clinical Database Registries
BREAST CANCER: DATA COLLECTED FROM BREAST CANCER PATIENTS RECEIVING TREATMENT AT CABRINI
1950
COLORECTAL: 2020-21 DATA CAPTURED ON PATIENTS FROM MONASH AFFILIATED HOSPITALS
5600
ARAD: PATIENTS WITH SURVEYS IN DATABASE
5820
PROSTATE: CURRENT ESTIMATED POPULATION COVERAGE
72%
Without some form of clinical audit, it is difficult to know if healthcare is being delivered effectively and even more difficult to demonstrate to others. The purpose of clinical database registries is to improve the safety and/or quality of healthcare provided to patients by collecting key clinical information from individual healthcare encounters. This enables risk-adjusted outcomes to be used in evidence-based quality improvement. Cabrini leads the development and application of a number of high quality clinical database registries. A number of new databases and registries were initiated in 2021.
Cabrini Research Annual Report 2020-21 Clinical Database Registries
DATABASE MANAGER SHARON GUO, LEAD RESEARCHER DR SHEHARA MENDIS
Upper Gastrointestinal (GI) cancers are those arising from the oesophagus, stomach, pancreas, liver, biliary tract and small bowel. One-year survival rates are less than 50 per cent in upper GI cancers and a mere 25 per cent in pancreatic cancer. At five years, survival rates drop to less than 25 per cent for all upper GI cancers.
Patients with upper gastrointestinal tract cancer generally require extensive diagnostic work-up prior to formulation of a management plan. Treatment may include systemic therapy (such as chemotherapy), radiotherapy or surgery, or a combination of these, depending on the type and extent of cancer. Patient, tumour and treatment factors impact upon how well the cancer can be cured or controlled.
CAPSTONE is designed to help researchers and the doctors who treat these cancers understand more about patients diagnosed with upper GI cancers – how they are diagnosed, what treatments they have, how well they do with these treatments, and ultimately use this information to improve care of these patients in the future.
We are delighted to welcome Database Manager Sharon Guo to the team, who joined us at the end of 2020 and brings with her a wealth of knowledge in the development of online databases.
Generous bequests from the late Veronica Choo Neo Png and Elaine Louise Benger have helped Cabrini Research pave the way in upper GI cancers by establishing the CAPSTONE registry. Veronica and Elaine’s legacies will make an important difference in how we help others.
Cabrini Gynaecological Oncology Registry
DATABASE MANAGER MATTHEW HORRIGAN, LEAD RESEARCHER PROFESSOR GARY RICHARDSON OAM
In Australia, it is estimated that there will have been 6652 newly diagnosed cases and 2096 deaths from gynaecological cancer in 2020. In total, 9.4 per cent of all female deaths from cancer will be attributable to gynaecological cancers.
The Cabrini Gynaecological Oncology Registry (CGOR) is a clinical quality data registry that is managed by Cabrini Research and reports a data subset to the National GynaeOncology Registry (NGOR). The objective of the database is to monitor and improve the quality of care that patients diagnosed with gynaecological cancers receive. The registry collects information about diagnosis, treatment and outcomes of women with gynaecological cancers. The process of improving healthcare systems by providing the hospital with the quality of care data takes time. CGOR is expected to benefit people diagnosed with these cancers in the future. The long-term aim for the registry is to help facilitate national and international benchmarking against agreed best practice. The collection and analysis of data will hopefully allow changes in practice that will improve key patient outcomes including overall survival, disease-free survival and quality-of-life.
A feature of this year has been working to set up the project so that it is ready to be launched. The standout highlight for the year will be officially launching the registry in the coming months. Eventually, the information collected will be used by the registry to generate reports for the hospital, publications, presentations and future research projects that require registry data.
The establishment of the CGOR was made possible by a generous bequest from the late Paula Reinders. Paula’s legacy will ensure more needed research is conducted into gynaecological cancers.
Lung Cancer Database
DATABASE MANAGER DR STEFANIE ELBRACHT-LEONG, LEAD RESEARCHER PROFESSOR GARY RICHARDSON
Lung cancer is the fifth most commonly diagnosed cancer in Australia, yet it consistently remains the leading cause of cancer related death1. Although incidence and mortality rates have improved over the past four decades, the fiveyear survival rate for lung cancer patient currently remains one of the lowest survival rates of any cancer in Australia at just 18 per cent averaged across all diagnosis stages2; and only 3.2 per cent of patients diagnosed with stage IV lung cancer will survive five years after diagnoses1 .
In order to achieve improvements in outcomes for patients living with lung cancer and alleviate the burden of this disease, more research is required. Real world data derived from population-based databases and clinical registries is increasingly recognised as an important complement to clinical trials3. Databases and registries are used to perform cohort studies and address clinical questions such as the efficacy of treatment, variations in clinical decision-making across treatment settings and influences on patient outcomes. When undertaken by investigators with clinical expertise and a thorough understanding of databases advantages and limitations, these studies can significantly enhance quantitative research regarding lung cancer treatment.
In order to expand the existing repertoire of cancer related databases at Cabrini, Dr Stefanie Elbracht-Leong was appointed as the lung cancer data manager at the beginning of 2021. The database is currently being developed in REDCap and will be used to capture clinical data alongside the patients’ experiences collected from patient-reported outcomes measures (PROMS) collected from diagnosis, treatment and follow-up.
Patient data collected will include but is not limited to demographics, histopathology and genomic analysis, stage of disease, exposure history, treatments and survival. Data will be obtained from prospective patients diagnosed with lung cancer being treated at both Cabrini Malvern and Brighton sites. Data will be extracted from their treating physician, medical records, clinical systems (PAS and CHARM), multi-disciplinary team meetings and hospital coded data that applies financial costs to diseases, health related problems and procedures performed in hospital (ICD10 coded extracts).
The database will be used for internal audits, generating reports to feedback to treating physicians and multidisciplinary team meetings. De-identified patient data will also be used by researchers to address important clinical questions. Overall the main aim for establishing the Cabrini lung cancer registry is to capture all lung cancer patients’ clinical data and to monitor health outcomes which will lead to improved quality of care of patients treated at Cabrini.
Dr Elbracht-Leong is also working collaboratively with the Victorian Lung Cancer Registry (VLCR) and the newly established Investigation of Health outcomes in Australian Lung cancEr (INHALE) registry. The Cabrini database is designed to facilitate semi-automatic transfer of clinical data for inclusion into both registries. Both registries provide complementary population-based information on the patterns of care for people diagnosed with lung cancer and assesses whether there is variation in health-related quality of life and survival following diagnosis of lung cancer in Victoria and across public and private hospitals4 .
Generous donations from Freda Castan have enabled the launch of the lung cancer database. Freda’s commitment will lead to improved quality of care of patients treated at Cabrini and support new research.
1 Australian Institute of Health and Welfare 2019. Cancer in Australia 2019. Cancer series no.119. Cat. no. CAN 123.
Canberra: AIHW. https://www.aihw.gov.au/reports/ cancer/cancer-data-in-australia 2 Noone, A., et al., SEER Cancer Statistics Review, 1975-2015,
National Cancer Institute. Bethesda, MD, https://seer. cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER web site, April 2018. 3 Booth, C.M., S. Karim, and W.J. Mackillop, Real-world data: towards achieving the achievable in cancer care. Nat Rev
Clin Oncol, 2019. 16(5): p. 312-325. 4 Victorian lung cancer Registry https://vlcr.org.au/
Cabrini Research Annual Report 2020-21 Clinical Database Registries
Prostate Cancer Outcomes Registry – Victoria
DATABASE MANAGER JUSTIN LANG, LEAD RESEARCHER PROFESSOR MARK FRYDENBERG
According to the World Health Organisation, Australia and New Zealand have one of the highest rates of prostate cancer. Fortunately, the improvement in screening and treatment is contributing to better survival rates. An important part of helping more men survive is enabling best-practice treatment and improvements in quality of life. The Prostate Cancer Outcomes Registry – Australia and New Zealand (PCOR-ANZ) database is building a population-based prostate cancer clinical registry to improve the quality of care provided to men diagnosed with prostate cancer. PCOR-ANZ aims to build understanding of the disease burden of prostate cancer, and aid the implementation of evidence-based support services.
The registry collects treatment data as well as surveying patients’ quality of life before and after treatment. By reporting on these factors, the goal is to reduce the negative effects of urinary, bowel and sexual function and increase general physical health and mental wellbeing. The reported quality indicator reports to clinicians provide a cross-sectional view of clinical and demographic aspects of prostate cancer and patterns of care, which helps understand the uptake of evidence-based practice. By contribution to a robust dataset, patient data across many institutions assists in the design of clinical trials and identification of questions for study. Overall, clinicians and institutions can be provided with mortality and morbidity data associated with various risk and treatment groups, both for their own patients and the wider cohort of men with prostate cancer. PCOR-ANZ seeks to deliver data that is fully representative of prostate cancer practice and outcomes across Australia and New Zealand in the near future.
• 3832 patients registered a prostate cancer diagnosis through Cabrini affiliated clinicians and recorded into
PCOR-Vic for screening and collection • The 2020 PCOR-ANZ annual report published the status of the database across Australia and New Zealand: • 39,953 patients notified to PCOR-ANZ 2015-2018 • 72% current estimated population coverage, with the aim of achieving 90% • Enrolled 244 clinical sites and 354 clinicians • 583 bi-national quality indicator reports delivered to healthcare providers • Cabrini patients were part of the dataset that showed for the first time that the majority of prostate cancer biopsy diagnoses in the ANZ registry were by the transperineal approach. • Further analyses can be found at https:// prostatecancerregistry.org/publications/annual-reports
DATABASE MANAGER KAREN OLIVA, LEAD RESEARCHER PROFESSOR PAUL MCMURRICK
The Cabrini Monash Colorectal Neoplasia Database (CMCND), funded by the Cabrini Monash University Department of Surgery, commenced in 2010 and was spearheaded by surgeons committed to excellence in the prevention, diagnosis and treatment of patients with colorectal cancer. The database continues to grow as an essential tool allowing surgeons to benchmark their performance amongst their peers by capturing data on patients with either bowel cancer or benign bowel neoplasia surgically treated at Cabrini Health and other Monash affiliated hospitals including The Alfred, Peninsula Health and Monash Partners Medical Centre, Dandenong. In 2013, the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) developed the Bi-National Colorectal Cancer Audit (BCCA), a minimally scaled duplicate version with participation from over 435 registered contributors across Australia and New Zealand contributing data on over 46,000 patients.
Bowel cancer is the second most common cause of cancer death in Australia. The database revealed only 14 per cent of patients present as a consequence of bowel cancer screening. Screening detects bowel cancer when it is at an early stage in people with no symptoms. This is when treatment is more likely to be effective. Screening can also find polyps. These are abnormal clumps of cells in the bowel. Polyps are not cancers, but may develop into cancers over time. Polyps can be easily removed, which reduces the risk of bowel cancer developing. In Australia, the National Bowel Cancer Screening program (NBCSP) invites all Australians aged 50-74 to complete screening biannually however our data indicates that 10 per cent of all patients diagnosed with bowel cancer are aged under 50 with seven per cent in the 40-49 age group, currently not captured by NBCSP. In May 2021, the US Preventive Services Task Force (USPSTF), recommended screening start at age 45. Guidelines in Australia today state that GPs can offer a Faecal Occult Blood Test (FOBT) every two years to people aged 45-49 who request it, thereby supporting the USPSTF recommendation which is very encouraging moving forward. We also know that 40 per cent of people diagnosed with cancer in Australia will be of working age (25–64 years). Our data indicates 35 per cent of patients diagnosed with bowel cancer are in that working age group and, depending on type of treatment received, may have a significant impact on work ability. By looking at what is being done now, the audit can suggest changes to improve care for people with bowel cancer in the future.
The database is housed and managed in an ISO 27001 certified environment and access to information is subject to strict protocols and procedures to ensure that privacy, confidentiality and ethical principles are maintained at all times. Data is analysed for data completeness based on 29 key elements and we are pleased to report that we consistently achieve almost 100 per cent capture ensuring integrity of data to complement translational research projects including: • Tissue microarray (TMA) program – TMAs allow multiple sources of tissue to be analysed simultaneously and allow for the rapid identification of prognostic and predictive biomarkers resulting in improved patient management. • Organoid program – Organoids are miniature replicas of both cancer and normal tissue, grown in the laboratory, providing scientists with model systems to assist researchers to quickly identify and optimise targeted anticancer therapies. • Human tissue-slice assay program – A model for studying the development of colorectal cancer as well as providing a novel platform for testing new immunotherapy drugs on thin slices of tumour tissue in culture.
Launch of the patient-reported outcome measures (PROMs) program There are many challenges we face such as raising screening rates, defining optimal care pathways and addressing many clinical research questions. We strongly believe the patient voice and bowel cancer experience truly matters and we are interested in gathering information from as many patients as possible about their quality of life before and after treatment. To this end, we launched the patientreported uutcome measures (PROMs) program at Cabrini and The Alfred hospitals in July 2021. The program will allow patients to inform clinicians seamlessly and securely, in realtime, of the symptomatic and functional outcomes they are experiencing. With what we learn, we’re hoping more patients will be able to get back to doing the things they love, with the people they care about most.
Cabrini Research Annual Report 2020-21 Clinical Database Registries
PROJECT MANAGER ASHLEY FLETCHER, DATABASE MANAGER VIBHASHA CHAND, LEAD RESEARCHER PROFESSOR RACHELLE BUCHBINDER AO
The Australian Rheumatology Association Database (ARAD) is a high-quality, national registry established in 2003. It includes over 6000 participants with inflammatory arthritis on biologic disease modifying antirheumatic drugs (bDMARDs) and other therapies. ARAD has 6-to-12 monthly questionnaires, data linkage to state and national data sets (MBS, PBS, cancer, death), over 30,000 person years of follow up and provides patient outcome reports to participating rheumatologists. ARAD supports the provision of better care and improved outcomes for patients being treated for rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and psoriatic arthritis.
Over 1000 participants enrolled in the patient experience of COVID-19 project; a collaboration between ARAD and COVID-19 Global Rheumatology Alliance. Looking at direct and indirect impacts of the first COVID-19 wave, it found a low level of difficulty and high confidence accessing required community health services. Also rapid uptake of telehealth and telephone reviews meant low level of difficulty accessing their GP and rheumatologist both remotely and in metropolitan areas.
Current analyses include socioeconomic factors associated with opioid and glucocorticoid use, serious infections and self-reported medication validity using linked PBS data and biologic treatment pathways (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) validated with linked PBS data.
ARAD is being upgraded to the Australian Arthritis and Autoimmune Biobank Collaborative (A3BC) to add biobanking capabilities and an expanded scope of data capture through the rollout of the A3BC-ARAD biobankregistry network. Recruitment is currently targeted towards patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis, vasculitis/ GCA and gout.
Cabrini Breast Cancer Database
DATABASE MANAGER MELISSA VEREKER, LEAD RESEARCHER PROFESSOR GARY RICHARDSON OAM
Breast cancer is the most common cancer and the second leading cause of cancer-related death in Australian women. One in seven Australian women will be diagnosed with breast cancer in their lifetime. The rate of mortality is decreasing due to earlier detection by screening mammography and advances in treatment.
The purpose of the Cabrini Breast Cancer Database is to improve the safety and quality of cancer treatment and outcomes for patients diagnosed with early and locally advanced breast cancer at Cabrini. The database was established in November 2016 and data has been collected for 1950 patients at Cabrini. The database records detailed information about diagnosis, tumour characteristics, stage, treatment and outcomes of patients with breast cancer, which allows health professionals to monitor standards of care at Cabrini and benchmark against national and international treatment standards.
Monitoring and measuring safety and patient care is an essential part of healthcare delivery. At the Cabrini breast cancer service, routine data collection is integrated with clinical practice to support the management of multidisciplinary team meetings, document patient treatment summaries and care plans, and drive quality activities and research. Data is captured throughout the patient’s journey, from diagnosis to follow-up care. The data is used to measure quality of cancer care, compliance with best practice guidelines, identify areas for service improvement, and ensure patients receive safe and effective treatment. The data will help improve the management, treatment and outcomes of future breast cancer patients, identify patients who may benefit from new treatments or clinical trials, and evaluate long-term effects and outcomes for treatment that was provided many years ago.
The Breast Cancer Database has been specifically designed to capture details about the complexity and variation in breast cancer tumours including hormone-receptor expression, as well as core biopsy, primary, and metastatic tumour information. The database also collects vital outcomes information including treatment modification, response to therapy, toxicity, disease progression, recurrence and cancer status at death.
Researchers and clinicians can request de-identified data from the Breast Cancer Database for research and audit purposes. The information stored on the database is confidential. All research projects must be approved by a research ethics committee.
Data from the Breast Cancer Database has been used for clinical and translational research projects including: • Evaluation of FGFR targeting in breast cancer through interrogation of patient-derived models. Chew NJ,
Lim Kam Sian TC, Nguyen EV, Shin S, Yang J, Hui MN,
Deng N, McLean CA, Welm AL, Lim E, Gregory P,
Nottle T, Lang T, Vereker M, Richardson G, Kerr G,
Micati D, Jardé T, Abud HE, Lee RS, Swarbrick A, Daly RJ,
Breast Cancer Research. Final draft pending. • Comparison of characteristics and treatment for women with screen-detected and non-screen-detected symptomatic breast cancer. Orlowski C, Keighley
L,Vereker M, Richardson G. • The use of neoadjuvant systemic therapy in early breast cancer as a guide to adjuvant treatment choices: a single institution review. McKie J, Antill Y, White M, Gregory P,
Morgan J, Taylor K, David S, Vereker M. Medical Student
Scholarship. • Depression and other psychological factors affecting work ability and the return to work among breast cancer survivors in Australia. Kim S, Kissane DW, Richardson
G, Senior J, Morgan J, Gregory P, Birks S, Ooi C, Lipton
L, Antill Y, Vereker M, Michael N, Bobevski I. (2021)
Psychooncology. doi:10.1002/pon.5802. • Modelling human breast cancer disease using an experimental in-vitro organoid culture system.
Richardson G, Lang T, Gregory P. • Impact of multidisciplinary team meetings on the management of patients with breast cancer at Cabrini
Hospital Melbourne. Orlowski C, Lai J, Antill Y,
Richardson G, Vereker M, David S. • ASCO quality oncology initiative program, breast cancer/gynaecological cancer. Orlowski C, Chow JA,
Richardson G.
